The Effect of GHRH Therapy on Myocardial Structure and Function in Congestive Heart Failure

Phase 2

Completed

• Conditions: Congestive Heart Failure
• Interventions: Drug: Growth hormone releasing hormone/ placebo

• Registration Number: NCT00791843
• Lead Sponsor: University of Pennsylvania

Brief Summary

PP1- The purpose of this study is to determine whether giving more of the hormone produced by everyone called growth hormone releasing hormone (GHRH) can improve heart function in individuals with congestive heart failure. You must be 50 years old or older, have a diagnosis of congestive heart failure, and have a high likelihood of having lower than normal growth hormone effect. GHRH is approved by the US FDA for treatment in children with growth hormone deficiency because GHRH stimulates Growth Hormone (GH). Its use for treatment of congestive heart failure in adults is investigational.

Growth hormone releasing hormone is a hormone produced in the brain. We will be using synthetic hormone made in the laboratory. It is identical to the hormone in the brain.

Many older people, due to aging have low levels of growth hormone. The aim of this study is to find out whether restoring growth hormone levels to the levels found in younger individuals and then maintaining those levels for 12 weeks will help strengthen heard muscles in older persons with congestive heart failure.

Detailed Description

PP1- The overall purpose of this study is to evaluate the effects of Growth Hormone Releasing Hormone (GHRH) on cardiac structure and function in subjects aged 50 years and older with a diagnosis of congestive heart failure in a single blinded (to the subject) randomized treatment/placebo study design. They will receive 12 weeks of drug or placebo, 6 weeks of washout, and 12 weeks of placebo or drug- whichever they didn't receive in the first 12 weeks. The hypotheses are: 1)normal aging is associated with evidence of declining somatotrophic activity exemplified by IGF-1 levels; 2) GHRH can raise levels of Growth hormone and IGF-1 in elderly individuals in a dose dependent fashion with minimal deleterious side effects; 3) GHRH will produce measurable increments in myocardial performance and structure and demonstrated growth of peripheral musculature; 4) the combination of these benefits will result in better quality of life due to the improvement of overall cardiac function.

Study Timeline

• Study Start: 2004-03
• Study First Submitted: 2008-11-13
• Study First Submitted QC: 2008-11-14
• Study First Posted: 2008-11-17
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2019-06
• Results First Submitted: 2019-06-19
• Results First Submitted QC: 2019-06-19
• Last Update Submitted: 2019-06-19
• Results First Posted: 2019-07-09
• Last Update Posted: 2019-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
GHRH and placebo	Growth hormone releasing hormone/ placebo	Everyone will receive 12 weeks of GHRH and 12 weeks of Placebo

Primary Outcome Measures

Name	Time	Method
PP1- Serum IGF-1 Levels, DXA, Resting Metabolic Rate, Total Body Water, 3-D Echo, Cardiac MRI, Dobutamine Stress Echocardiogram, Ergometry, General Health Assessment, Physical Exam	baseline, 12, 18, and 30 weeks

Trial Locations

Locations (1)

Massachusetts General Hospital/ Geriatric Research; 🇺🇸 Boston, Massachusetts, United States